XRD(XRPD) and SAXS characterisation of pharmaceuticals and biopharmaceuticals

2024-07-31

We offer: for small molecule drugs: XRD(XRPD) for - drug substance (API) and excipients: XRD (XRPD) quantification of polymorphs, XRD (XRPD) quantification of crystalline and amorphous content; compatibility studies; XRD(XRPD)for intermediates and finished dosage forms: XRD(XRPD) charaterisation of effects of processing, quantification of polymorphism including FDF's; stability studies; QC testing of production batch (down to 24h turnaround) SAXS for Biologics and biosimilars (in solution): SAXS investigation of properties of therapeutic proteins during development and manufacturing; studying particle size, shape and envelope structure; accessing conformation and aggregation pathways; SAXS investigation of drug delivery systems (monomers SAXS investigation of solids and powders: probing specific surface (surface per unit volume) particle size and pore size distribution (nanoporosity) within the range of 1-60nm. Patents (relevant to crystalline and amorphous forms): Assistance with drafting, XRD(XRPD),SAXS,WAXS properties for new patent; crystallographic and meso-scale properties for new patent; prior-art, clearance and invalidation research; crystallographic and image data analysis Drug product identity: counterfeit product analysis, characterisation of drug product related to the suspected patent infringement

DANNALAB offers advanced characterization of pharmaceuticals based on X-Ray Powder Diffraction (XRD, XRPD) and Small Angle X-Ray Scattering (SAXS).

For drug substances and products we offer in-depth assessment/monitoring of critical quality attributes based on the advanced physical characterisation.

We are serving Europe, Americas and Asia.

We focus on characterization of active ingridients and intermediates, drug delivery systems and finished drug products. Important features, which we can access in the finished drug products, include polymorphism and crystallinity for small molecule drugs and structure within aggregation pathways for biologics. Characterization study is often combined with the analysis of the available patents

Dannalab